Indication

Voltaren^® Gel is a nonsteroidal anti-inflammatory drug (NSAID) used for the relief of joint pain of osteoarthritis in the knees, ankles, feet, elbows, wrists, and hands. Voltaren Gel has not been studied for use on the spine, hip, or shoulder.

IMPORTANT SAFETY INFORMATION
for Voltaren Gel

What is the most important information you should know about medicines called Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines, like Voltaren Gel, may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

• with longer use of NSAID medicines
• in people who have heart disease

NSAID medicines, like Voltaren Gel, should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

NSAID medicines, like Voltaren Gel, can cause ulcers and bleeding in the stomach and intestines at any time during treatment.

• Ulcers and bleeding can happen without warning symptoms and may cause death
• The chance of a person getting an ulcer or bleeding increases with older age

NSAID medicines should only be used:

• at the lowest dose possible for your treatment
• for the shortest time needed

Do not use Voltaren Gel if you are allergic to diclofenac (the active ingredient in Voltaren Gel) or if you have had asthma, hives, or other allergic-type reactions after taking aspirin or other NSAIDs.

Tell your healthcare provider:

• if you have a history of ulcers or bleeding in the stomach or intestines, or kidney or liver problems, or heart failure
• about all of your medical conditions
• about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects
• if you are pregnant or breastfeeding. Voltaren Gel should not be used late in pregnancy

NSAIDs, including Voltaren Gel, can lead to high blood pressure or worsening of high blood pressure, which may add to the increased risk of heart attack and stroke.

Possible serious side effects include life-threatening skin and allergic reactions.

Get emergency help right away if you have any of the following symptoms: shortness of breath or trouble breathing, chest pain, weakness in one side of your body, slurred speech, or swelling of the face or throat. Stop using Voltaren Gel and call your healthcare provider right away if you have: skin rash or fever with blisters.

Do not use Voltaren Gel on the same skin site that was treated with other topical products, such as sunscreens, cosmetics, lotions, moisturizers, or insect repellents.

Other information about NSAIDs:

• Aspirin, which is an NSAID, can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines

You should not use Voltaren Gel with oral NSAIDs.

The most common side effects reported in studies using Voltaren Gel were application site reactions, including dermatitis (reported in 7% of treated patients).

Use Voltaren Gel exactly as prescribed by your healthcare provider.

• Apply Voltaren Gel to clean, dry skin that does not have any cuts, infections, or rashes
• Avoid exposing skin where you apply Voltaren Gel to sunlight and artificial light, such as tanning booths
• Do not get Voltaren Gel in your eyes, nose, and mouth

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information about Voltaren Gel, please see the
full Prescribing Information, including the Medication Guide for patients.